Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 8:14 PM
Study NCT ID:
NCT01066351
Status:
UNKNOWN
Last Update Posted:
2010-02-10
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103998', 'term': 'epoetin beta'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-09', 'studyFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2010-02-09', 'lastUpdatePostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end-point of this study is the development of AKI in placebo group compared with EPO group.', 'timeFrame': '1.5 year'}], 'secondaryOutcomes': [{'measure': 'The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups', 'timeFrame': '1.5 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute kidney injury', 'erythropoietin', 'cardiac surgery'], 'conditions': ['Acute Renal Failure']}, 'referencesModule': {'references': [{'pmid': '19494484', 'type': 'BACKGROUND', 'citation': 'Song YR, Lee T, You SJ, Chin HJ, Chae DW, Lim C, Park KH, Han S, Kim JH, Na KY. Prevention of acute kidney injury by erythropoietin in patients undergoing coronary artery bypass grafting: a pilot study. Am J Nephrol. 2009;30(3):253-60. doi: 10.1159/000223229. Epub 2009 Jun 2.'}, {'pmid': '19077684', 'type': 'BACKGROUND', 'citation': 'Bahlmann FH, Fliser D. Erythropoietin and renoprotection. Curr Opin Nephrol Hypertens. 2009 Jan;18(1):15-20. doi: 10.1097/MNH.0b013e32831a9dde.'}, {'pmid': '19005302', 'type': 'BACKGROUND', 'citation': 'Bernhardt WM, Eckardt KU. Physiological basis for the use of erythropoietin in critically ill patients at risk for acute kidney injury. Curr Opin Crit Care. 2008 Dec;14(6):621-6. doi: 10.1097/MCC.0b013e328317ee82.'}, {'pmid': '39301879', 'type': 'DERIVED', 'citation': 'Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.'}, {'pmid': '23829828', 'type': 'DERIVED', 'citation': 'Tasanarong A, Duangchana S, Sumransurp S, Homvises B, Satdhabudha O. Prophylaxis with erythropoietin versus placebo reduces acute kidney injury and neutrophil gelatinase-associated lipocalin in patients undergoing cardiac surgery: a randomized, double-blind controlled trial. BMC Nephrol. 2013 Jul 5;14:136. doi: 10.1186/1471-2369-14-136.'}], 'seeAlsoLinks': [{'url': 'http://www.nephrothai.org/', 'label': 'The Nephrology Society of Thailand'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in CKD patients undergoing cardiac surgery.', 'detailedDescription': 'Acute kidney injury (AKI)occur 7.7-42% after cardiac surgery. The incidence of AKI requiring renal replacement therapy following coronary artery bypass grafting (CABG) surgery was 0.7-3.5% and increase mortality rate. Erythropoietin (EPO) is now considered a novel anti-apoptotic and anti-inflammatory action. The present study was designed to evaluate the administration of EPO as a means of preventing AKI in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years.\n* serum creatinine levels \\> 1.2 mg/dL and baseline creatinine clearance levels \\< 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)\n* patients who need cardiac surgery\n\nExclusion Criteria:\n\n* patients with acute kidney injury\n* end stage renal disease (requiring dialysis)\n* unstable renal function (as evidenced by a change in serum creatinine of \\> 0.5 mg/dL, or \\> 25%, within 14 days prior to the study)\n* allergy to any of erythropoietin\n* suffered from congestive heart failure, cardiogenic shock or emergent cardiac surgery.\n* receiving erythropoietin within 14 days before the study'}, 'identificationModule': {'nctId': 'NCT01066351', 'briefTitle': 'Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'MTU-E-1-57/52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erythropoietin', 'description': 'The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.', 'interventionNames': ['Drug: beta erythropoietin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'beta erythropoietin', 'type': 'DRUG', 'otherNames': ['Recormon'], 'description': 'The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.', 'armGroupLabels': ['Erythropoietin']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12121', 'city': 'Khlong Luang', 'state': 'Pathumtani', 'country': 'Thailand', 'facility': 'Adis Tasanarong', 'geoPoint': {'lat': 14.06467, 'lon': 100.64578}}], 'overallOfficials': [{'name': 'Adis Tasanarong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thammasat Universuty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Adis Tasanarong', 'oldOrganization': 'Faculty of Medicine, Thammasat University (Rangsit Campus)'}}}}